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Seminar on

GMP and Regulatory Expectations for Early IND Products

Date & Time: April 05th and April 06th 2012

9 AM PDT to 5 PM PDT

Duration: 2 Days

Instructor: Steven S Kuwahara

Location: San Diego

Price : $1695.00


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Instructor Profile: Steven S Kuwahara Founder & Principal, GXP Biotechnology, LLC

Overview: Any pharmaceutical worker who must deal with products both in early and latter phases of development should attend this course in order to be aware of the regulatory requirements that will affect

Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories . Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production. ...more

operations dealing with these products. Any pharmaceutical worker who must deal with products both in early and latter phases of development should attend this course in order to be aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have modified the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time some of the things that may appear to have changed, have not, and the pharmaceutical worker should be aware of this. This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials.

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Day 1, April 5, 2012 Lecture 1: Very Early Stages l

The need for documentation of matters that will affect downstream work.


The effects of ICH Q8 ¡ Impact on R & D activities ¡ Risk analysis and design control at this stage.

Lecture 2: GLP Requirements l

Animal studies


¡ Toxicology and pharmacokinetics. Estimating the Maximum Safe Starting Dose ¡ A review of the guidance document.

Lecture 3: Early Pre-IND Studies l

l l

Understanding exploratory Studies ¡ Definitions and the IND that will be withdrawn. Orphan Drugs Drugs studied under the Animal Rule ¡ What they are and how to conduct the studies.

Lecture 4: Meetings and Preparing for the IND l


Information required for the Phase 1 IND ¡ The CMC requirements that will be needed. Pre-IND Meetings with FDA

Day 2, April 6, 2012 Lecture 5: GMPs for Phase 1 IND products l

The scope of the guidance document


The second guidance document covering the GMPs.

Lecture 6: GMPs for Phase 1 continued l

A presentation covering what GMPs are required at this stage.


What has been omitted from the GMPs for Phase 1.

Lecture 7: Requirements for Phase 2 INDs l l l

The full GMPs resume, but do they? Phase 2 studies and the transition to full GMPs. CMC requirements.

Lecture 8: Preparing for IND Meetings l

Phase 1 meetings


Pre-phase 2 meetings Phase 2 meetings


Click here to register for this webinar Who Will Benefit: l l l l l


Directors Managers Supervisors, and lead workers in Regulatory Affairs Quality Assurance and Quality Control Workers who will prepare GMP documents for early phase products as well as those who will review these documents Regulatory affairs workers who will need to deal with submissions covering early phase products.

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

GMP and Regulatory Expectations for Early IND Products - US Seminar 2012 at San Diego  

Any pharmaceutical worker who must deal with products both in early and latter phases of development should attend this course in order to b...

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